FDA Requiring Labeling Changes for Opioid Pain Medicines, Opioid Use Disorder Medicines Regarding Naloxone
Goal is to Help Reduce Opioid Overdoses and Deaths
The U.S. Food and Drug Administration today announced it is requiring that labeling for opioid pain medicine and medicine to treat opioid use disorder (OUD) be updated to recommend that as a routine part of prescribing these medicines, health care professionals should discuss the availability of naloxone with patients and caregivers, both when beginning and renewing treatment. Naloxone is a medicine that can be administered by individuals with or without medical training to help reduce opioid overdose deaths. If naloxone is administered quickly, it can counter the overdose effects, usually within minutes.
“Even during this global pandemic, we have continued to prioritize addressing the opioid crisis,” said FDA Commissioner Stephen M. Hahn, M.D. "Today’s action can help further raise awareness about this potentially life-saving treatment for individuals that may be at greater risk of an overdose and those in the community most likely to observe an overdose. We will use all available tools to address this crisis, and we know efforts to increase access to naloxone have the potential to put an important medicine for combatting opioid overdose and death in the hands of those who need it most – those at increased risk of opioid overdose and their friends and family.”
2020 AMA Opioid Task Force Drug Overdose Report
Sharp reductions in prescription opioid supply, continued increases in PDMP use, but staggering increase in fatalities involving illicit opioids, methamphetamine, heroin and cocaine were demonstrated last year. AMA calls on policymakers and others to remove barriers to evidence-based care for patients with pain and those with a substance use disorder.
Although fatal opioid overdoses hit a record high in 2019 — and the Covid-19 pandemic threatens to make matters worse — the latest report from the American Medical Association's Opioid Task Force finds that prescriptions for these drugs decreased last year for the sixth year in a row. There was a 37% decrease in opioid prescriptions last year — from more than 244 million in 2014 to around 154 million in 2019. Other trends also point to higher scrutiny of these prescriptions: There was a 64% increase since 2018 in physicians' use of state drug monitoring programs, for instance, which are online databases meant to track prescriptions of controlled substances. And more doctors are also prescribing naloxone: More than 1 million prescriptions of the drug were dispensed last year, which is more than double the number in 2018.
> 2020 AMA Opioid Task Force Drug Overdose Report
> End the Epidemic, American Medical Association (AMA) website
COVID-19 Resources and Substance Use Disorders
The COVID-19 pandemic presents unique challenges for people with substance use disorders and in recovery. The following resources from Dr. Nora Volkow, NIDA Director, may help. See interviews with Dr. Volkow and read the FAQs on COVID-19 and Addiction/Substance Use Disorder.
Many People Treated for Opioid Overdose in Emergency Departments Die Within 1 Year
This study from the National Institute on Drug Abuse (NIDA) reported:
- About 1 in 20 patients treated for a nonfatal opioid overdose in an emergency department died within 1 year of their visit, many within 2 days.
- Two-thirds of these deaths were directly attributed to subsequent opioid-related overdoses.
- Immediate treatment for substance use disorder in the ED that continues after discharge is needed to reduce opioid-related deaths.
Citation: NIDA. (2020, April 2). Many People Treated for Opioid Overdose in Emergency Departments Die Within 1 Year. Retrieved from https://www.drugabuse.gov/news-events/nida-notes/2020/04/many-people-treated-opioid-overdose-in-emergency-departments-die-within-1-year on 2020, June 10
The Opioid Crisis and the Black/African American Population: An Urgent Issue
Substance Abuse and Mental Health Services Administration (SAMHSA), U.S. Department of Health and Human Services (HHS) by SAMHSA’s Office of Behavioral Health Equity, March 2020
The opioid crisis has not abated and has had a significant impact on African American communities. This issue brief presents recent data on prevalence of opioid misuse and death rates in the Black/ African American population; contextual factors and challenges to prevention and treatment; innovative outreach and engagement strategies to connect people to evidence-based treatment; and the importance of community voice.